The pharmaceutical industry, chemical companies, consumer product manufacturers and many other industries need accurate and reliable tools with which to determine the safety, or potential toxicity, of their products. For many years animal tests have been relied upon to provide this toxicity information, but recently the use of these tests has been called into question for both scientific and ethical reasons. The National Academies have addressed this issue with a report Toxicity Testing in the 21st Century: a Vision and a Strategy that envisions a future where toxicity testing relies on three basic components: high-throughput instrumentation, human tissue models as target tissues for the molecules to be screened, and knowledge of toxicity pathways[unreadable]. RegeneMed, will translate its former world-wide validated human 3D full-thickness skin tissue, Skin2 into high throughput 96-well plate formats and characterize its tissue-specific function and ability to meet current and expected OECD Test Guidelines for irritation and corrosion. Phase II contract activities would synergize with RegeneMed's ongoing efforts to have: 1) OECD accepted in 3D skin models for several acute endpoints by 2012, 2) a model for genotoxicity that will be available by 2012 for validation, and 3) mechanistic models in skin that will help address the 2013 EU deadlines for carcinogenicity, reproductive and repeat dose toxicity using human 3D skin and liver. RELEVANCE TO PUBLIC HEALTH;Worldwide research, regulatory and legislative groups are reaching a consensus that traditional animal testing must be replaced by more predictive, less costly, faster and more humane methods. Human 3D tissue cultures provide human preclinical prediction and are achieving regulatory acceptance and routine use.